Index

Introduction

Surgical Technique

Set Details

Radiographic Cases

FeaturesIndications

1

4

11

17

2-33

1114

4-8899

10

2.0-2.5-3.0-3.5 mm4.0-5.0 mm

Femoral Surgical TechniqueTibial Surgical Technique

Ulna Radius Surgical TechniqueHumeral Surgical Technique

Removing of the Implant

20˚

14˚

Locking TEP (titanium elastic pin) has been developed to take advantage of more than the titanium elastic pin by giving slope to the front the elastic intramedullary nail system to improve stability and providing easy of application.Axial and rotational stability are increased by locking with the grooved hill of nail located in the fixing hole in the end part.Minimally invasive surgical approach is preferred in the treatment of long bone fractures in pediatric orthopaedics. This system is designed for the treatment of long bone fractures seen in children and young people. This system can also be used in the treatment of humerus and upper extremity diaphyseal fractures in adults and in the femur and tibia fractures for small-statured patients.L-TEP has significant advantage for fixation of diaphyseal fractures of narrow medullary canal.There are elastic nails �at, �exible, having di�erent diameters and lengths also corrective, generating distraction and reduction forces beside this curved nails are available increasing application and stability.Front slope of these nails are formed at the production stage appropriately with the surgical technique.L-TEP is an intramedullary nailing system locking on the bone cortex with its end to provide rotational stabilization.It is based on the symmetrical bracing action of two elastic nails inserted into the metahaphysis, each of which bears against the inner bone at three points.This produces the following four properties: �exural stability, axial stability, translation stability and rotational stability. All four are essential for achieving optimal results.

L-TEP is produced with Ti6Al7Nb alloy suitable with ASTM F 1295/ISO 5832-11 standard and it has �exible capabilities reverted back after bending for di�erent degrees. The system is available in two di�erent sets of nails located; 2.0-2.5-3.0-3.5 mm a set of small nails, major ones 4.0-5.0 mm.Straight and front slope nails are placed in the set having lengths of 200-250-300-350 and 400 mm.

It is designed inclined both end parts of the front beveled to provide easy application and comfortable detection interior through broken line in order to improve stability. It is formed as bayonet type by giving 315 mm radius to its 5 cm end of the beveled nails for metaphyseal fixation.

Introductions

Features

ISO 9001:2008ISO 13485:20031

10˚

14° slope is given at the 5.5 cm section of the nail placed at the end. In the final part of the nails 20° angled screw holes are available to lock screws. As two locking screw holes place in the major nails (4.0 ve 5.0 mm) as the others (2.0-2.5-3.0-3.5 mm) have just one hole for the locking screw.These two screw holes placed at the end of the major nails are designed 10° to each other to provide fixation of screws.Fixation of diaphyseal fractures including narrow medullary canal, L-TEP provides advantages according to �exibility in comparison to the other nails.L-TEP has similar application methods like classic elastic nails. L-TEP provide intramedullary fixation with three point principle like classic elastic nails. Besides it provides fixation with locking screw at the end of the nails as it is defined in the name of the product.

The significant feature of the L-TEP is resolving/minimising of migration and irritation problems occurring frequently in the TEN applications with increasing stability.

2

Position of lateral nails in opposite directions applied distal of the femur

Medial Nail

Lateral Nail

Position of the Lateral and Medial nails applied from lateral of the Proximal Humerus

Another feature o�ered by the system is no need to form the nails during the operation with the previously shaped nails. This feature significantly shortens the operation time.

It is an advantage that there is also straight form of nails in the set container allowing the user bending or curving the L-TEP according to operation requirements.There are two di�erent types of this special curved L-TEP as lateral and medial As known elastic nails are generally applied with in pairs.Lateral nail placed in the set container is used in the double nailing application by fixing the nails opposite direction (medial & lateral) to each other.As an example; all the end of nails has to direct to the side of application in the place of metaphyseal fixation (final position) during the opposite to each other proximal tibia or distal femur double nailing application. In other words, after the application, the end of the nail entered from the lateral has to direct to lateral cortex and the end of the nail entered from the medial have to direct to medial cortex.There may always not be the opportunity of fixation of the implant by opposite to each other (medial & lateral) during the double nailing application. For example, both of the nails have to be applied from lateral in the application of humerus or femur proximal entrances.

Medial nails are designed with diameters of 3.5 mm and 4.0 mm according to these requirements.Fixation direction of end point in the metaphysis is designed to reach to medial cortex despite the entrance from lateral of the other nail as the first one entered from the lateral reaches to lateral cortex.To summarize; L-TEP are designed suitable for minimal invasive surgical approach and they can be double applied.For this purpose, L-TEP have the feature of applicability of both of nails from the lateral entrance or as one of from medial entrance the other one from the lateral.L-TEP can be implanted with the antegrade or retrograde techniques providing protection of epiphyseal line.

L-TEP is used for intramedullary fixation of diaphyseal and metaphyseal fractures of long bones in children.

Indication range of L-TEP varies according to the patient's age, fracture zone and type of fracture.

L-TEP can be used at the long bones of upper and lower extremity (transverse, oblique, spiral short diaphyseal fractures and metaphyseal fractures) for children aged between 3-15 years with intramedullary nailing system.

Also it can be used for adults to fix humerus and forearm diaphyseal fractures and metaphyseal fractures.

Indications

3

Pre-operative planning should be done carefully. Input point of nail and final location of the end part have to be placed out of the articular capsule for the protection of epiphysis and epiphyseal plate and can vary according to the anatomical region to be appliedExample surgical technique: Standard technique is applied for femoral transverse shaft fractures can be based as a beginning.

The narrowest part of the medullary canal is measured and nail diameter has to be one-third of it. Reduction is made. Full rotation control is made according to the intact limb. The entry point of the locking TEP; it should be 2.5 cm proximal to the distal physis one another as opposite, medial and lateral. Take care not to damage growth plate. It is important for symmetrical connection to open medullary space concordant from both parts.

The length of the nails should be adjusted in the pre-operative period. The length of the nail should be short 4 cm from the distance between proximal and distal physis of the fractured bone.

L-TEP is entered into the bone by passing the cortex with Awl and reached the medulla by using Curved Awl with 45° to the shaft axis. Entry hole has to be 1 mm greater than the nail diameter. Same process has to be repeated for the opposite entry hole.

1 NAIL ENTRY POINT AND OPENING OF THE MEDULLARY CANAL:

Surgical Techique

Femoral Surgical Technique

4

The nail is inserted into the open medullary canal as close as possible to the fracture line. Second nail is inserted like the first one. The first cross encounter of the nails is provided on the metaphyseal region. First nail is transmitted by hand or Hammer to the fracture line. Impactor-Extractor Rod can be used during the process. Second nail is transmitted like the first nail.Fracture reduction can be done by turning the nails.End of nail is sent a few centimetres forward to the fracture to provide fracture fragments to hold on safely.The nails are sent through the fracture line in sequence by making last reduction.Second cross encounter of the nail is provided after passing the fracture zone and end points of nails not to damage to femoral calcar.

Under favour of the Nail Inserter, last part of nail can be implemented and providing the right position of the nail without any necessity of �uoroscopy.

2 INSERTING THE NAIL:

5

Final stabilization is made as 2 cm distal to proximal epiphys line with the help of �uoroscopy control of nail position.At this step, the Nail Inserter is taken out.The Final Impactor makes the ending part of the nail to get into the cortex with slight strikes of the Hammer.

The next procedure is to drill with Bone Drill with constant angle by installing the Threaded Drill Sleeve to lock the hole of the nail.

3

4

THE FINAL POSITION OF THE NAIL:

THE IMPLEMENTATION OF THE LOCKING SCREW OF THE NAIL:

6

Length of screw is determined with the Depth Gauge.

The appropriate locking screw is inserted through the nails locking hole with a Screwdriver to fix the nails. The operation is terminated by the suture of the incision area.

7

It is always fixed in tibia antegradly not to damage entry point of tendon at distal, so it is contraindicated in the fractures of proximal tibia. Plane of the nails is settled diagonally because of triangular anatomical structure of the tibia and in this case, it is tent to recurvate tibia by causing tension on the posterior.

The entry point is determined as antero-lateral and antero-medial in the 1-2 cm distal of the proxymal physics. The first nail is transmitted  by passing through the fracture line with Inserter and anatomic reduction is provided before proceeding adhesion in the distal metaphysis.After all, detection is completed by furthering second nail to the fulcrum.

Monolateral application method is preferred in fracture of femoral diaphysis close to distal and fracture of distal metaphysis.This technique is di�erent from the shaft fracture fixation technique.Entrance area is opened approximately 1.5 cm from the antero-lateral of the subthrocanteric area longitudinally for the first nail. Second nail is inserted 1 cm lateral to the first nail’s entry point with the same principle as the first one.Medial nail is used to provide support in the medullary canal at the level of fracture. First and second nail are inserted to fracture line on the base of three-points principle. The nails are positioned furthering with TEP Final Impactor after the nails’ alignment in order to provide support against each other for reduction and detection.Fracture fixation is completed with inserting the nail locking screws.

5 LATERAL AND MEDIAL NAILING TECHNIQUE:

Tibial Surgical Technique

8

Just one nail is inserted individually in the radius and ulna intramedullary applications because both bones generate one unit.A single nail is used on both radius & ulna to fill 60% of the medullary canal.It is recommended that the nail should always be placed in a retrograde approach on the radius to avoid the risk of damage to the radial nerve which is close to elbow jointEntry point is determined at the proximal of radial steloid or on the lister tubercul (from approximately 1 cm proximal of physis) for radius diaphysis fractures. Incision is made in distal 2 cm in length toward dorso-radial by saving radial nerve.Ulna entry point is determined from posterior of olecranon antegradly or 2 cm from proximal metaphysis to olecranon apophysis.

Monolateral antegrad technique is used to treat fractures of the distal humerus. In this technique, entry point is determined at the level of lateral humerus deltoid muscle connection point.

The nail entry points are opened to nails approximately located on 1.5 cm distal and 1 cm lateral from each other.Fracture fixation is made suitable via determined principles.Monolateral retrograde technique is used on posterior implanting zone to treat fractures of the proximal humerus and humerus shaft.

In this technique, entry point is located exterior postero-lateral of the lateral supracondylar hill for each nails. Nails are applied for humerus with same standard techniques used for tibia and forearm fractures.

Ulna Radius Surgical Technique

Humeral Surgical Technique

9

Locking screw is removed with a screw driver compatible with locking screw of the nail. Screw is pulled to the surface of the bone outwardly locking nail is inserting of extract hook with the screw hole. It can be used as shown in figure above with Impractor-Extractor Rod, the rear portion of the hook in the meantime.

All of the nail is pushed out of the bone with Impractor-Extractor Rod and slightly strikes of Hammer, Nail Inserter is inserted the section once taken out of the bone 2.5 cm section of the end of nails.

Removing of the Implant

10

1 2 3 4

NO

12

3

4

CATALOG NO

101008352720093583527250935835273009358352735093583527400935835272000358352725003583527300035835273500358352740003582020400035

UBB NO

86999310204108699931029437869993102944486999310294448699931020618869993100932386999310293768699931009378869993102938386999310195518699931029529

DESCRIPTION

1. DESIGN TRAYLOCKING TI ELASTIC PIN (M-TEP) 3.5X200 MMLOCKING TI ELASTIC PIN (M-TEP) 3.5X250 MMLOCKING TI ELASTIC PIN (M-TEP) 3.5X300 MMLOCKING TI ELASTIC PIN (M-TEP) 3.5X350 MMLOCKING TI ELASTIC PIN (M-TEP) 3.5X400 MMLOCKING TI ELASTIC PIN (L-TEP) 3.5X200 MMLOCKING TI ELASTIC PIN (L-TEP) 3.5X250 MMLOCKING TI ELASTIC PIN (L-TEP) 3.5X300 MMLOCKING TI ELASTIC PIN (L-TEP) 3.5X350 MMLOCKING TI ELASTIC PIN (L-TEP) 3.5X400 MMLOCKING TI ELASTIC PIN (STRAIGHT) 3.5X400 MM

QTY

122222222222

Set Details

2.0-2.5-3.0-3.5 mm Locking TEP

11

5 7 9 8 6

NO

56

78

79

7

CATALOG NO

102008352720002083527250020835273000208202030002083527200025835272500258352730002582020300025835272000308352725003083527300030835273500308352740003082020400030

UBB NO

86999310090578699931029338869993100910186999310294998699931009149869993102934586999310091948699931029505869993100923186999310293528699931009286869993102936986999310195448699931029512

DESCRIPTION

2. DESIGN TRAYLOCKING TI ELASTIC PIN (L-TEP) 2X200 MMLOCKING TI ELASTIC PIN (L-TEP) 2X250 MMLOCKING TI ELASTIC PIN (L-TEP) 2X300 MMLOCKING TI ELASTIC PIN (STRAIGHT) 2.0X300 MMLOCKING TI ELASTIC PIN (L-TEP) 2.5X200 MMLOCKING TI ELASTIC PIN (L-TEP) 2.5X250 MMLOCKING TI ELASTIC PIN (L-TEP) 2.5X300 MMLOCKING TI ELASTIC PIN (STRAIGHT) 2.5X300 MMLOCKING TI ELASTIC PIN (L-TEP) 3X200 MMLOCKING TI ELASTIC PIN (L-TEP) 3X250 MMLOCKING TI ELASTIC PIN (L-TEP) 3X300 MMLOCKING TI ELASTIC PIN (L-TEP) 3X350 MMLOCKING TI ELASTIC PIN (L-TEP) 3X400 MMLOCKING TI ELASTIC PIN (STRAIGHT) 3X400 MM

QTY

122222222222222

12

10 11 2011 14 13 17 18 21 26 25 19 24 16 15 12 22-23

NO

10111213141516171819202122232425

26

CATALOG NO

10300082100020350831000203508061000008040700003000821000000408310000004011940030090338570000022310130020020058000200200500050002000452017021014520170201010100102271000002

1040021227001027212270012272122700142721227001627212270018272122700202721227002227212270024272122700262721227002827212270030272122700322721227003427212270036272122700382721227004027

00560270125

UBB NO

869993102975886999310297728699931029925869993102991886999310297108699931029734869993102815786999310296118698673450400869993102958186986734970238699931029048869993102905586986734411878699931000122

8680858420131868085842015586808584195008680858403721868085840373886808584037458680858403752868085840376986808584037768680858403783868085840379086808584202858680858420292868085842030886808584203158680858420322

8699931010275

DESCRIPTION

3.DESIGN TRAYLOCKING TEP BENDER Ø 2 MM – Ø 3.5 MMLOCKING TEP INSERTER Ø 2 MM- Ø 3.5 MMLOCKING TEP IMPACTOR-EXTRACTOR RODLOCKING TEP FINAL IMPACTORAWL 4 MMCURVED AWL 4 MMBONE HAMMER SMALL WITH SLOTTED ENDLOCK. NAIL EXTRACTOR HOOKBONE DRILL 2.0X130 MMTHREADED DRILL SLEEVE Ø 2 FOR SMALL HEAD SCREWSDEPTH GAUGE (0-50 MM)SCREW DRIVER QUICK TIP HEXAGONAL 1.7XØ4X52 MMSCREW DRIVER HEX.QUICK TIP WITH HOLDER 1.7XØ4X52MMSOFT SCREW DRIVER QUICK SMALLPIN CUTTER UP TO Ø 5

L-TEP SCREW TRAY Ø 2-3.5 MMNAIL FIXATION SCREW 2.7 X 10 MMNAIL FIXATION SCREW 2.7 X 12 MMNAIL FIXATION SCREW 2.7 X 14 MMNAIL FIXATION SCREW 2.7 X 16 MMNAIL FIXATION SCREW 2.7 X 18 MMNAIL FIXATION SCREW 2.7 X 20 MMNAIL FIXATION SCREW 2.7 X 22 MMNAIL FIXATION SCREW 2.7 X 24 MMNAIL FIXATION SCREW 2.7 X 26 MMNAIL FIXATION SCREW 2.7 X 28 MMNAIL FIXATION SCREW 2.7 X 30 MMNAIL FIXATION SCREW 2.7 X 32 MMNAIL FIXATION SCREW 2.7 X 34 MMNAIL FIXATION SCREW 2.7 X 36 MMNAIL FIXATION SCREW 2.7 X 38 MMNAIL FIXATION SCREW 2.7 X 40 MM

CONTAINER 560X270X150 MM

QTY

1211111112211111

14444444444444444

1

13

23 41

NO

12

3

4

CATALOG NO

11100835272009408352725094083527300940835273509408352740094083527200040835272500408352730004083527350040835274000408202040004082020400050

UBB NO

869993102042786999310294518699931020526869993102946886999310206258699931009415869993102939086999310094608699931029406869993101956886999310295368699931029543

DESCRIPTION

1.DESIGN TRAYLOCKING TI ELASTIC PIN (M-TEP) 4X200 MMLOCKING TI ELASTIC PIN (M-TEP) 4X250 MMLOCKING TI ELASTIC PIN (M-TEP) 4X300 MMLOCKING TI ELASTIC PIN (M-TEP) 4X350 MMLOCKING TI ELASTIC PIN (M-TEP) 4X400 MMLOCKING TI ELASTIC PIN (L-TEP) 4 X200 MMLOCKING TI ELASTIC PIN (L-TEP) 4 X250 MMLOCKING TI ELASTIC PIN (L-TEP) 4 X300 MMLOCKING TI ELASTIC PIN (L-TEP) 4X350 MMLOCKING TI ELASTIC PIN (L-TEP) 4X400 MMLOCKING TI ELASTIC PIN (STRAIGHT) 4X400 MMLOCKING TI ELASTIC PIN (STRAIGHT) 5X400 MM

QTY

1222222222211

4.0-5.0 mm Locking TEP

14

NO

56

78910111213141516171819

20

CATALOG NO

11200835272000508350272505083527300050835273500508352740005008210000055083100000550821000405008310004050080610000080407000030001194003009033857000002231020002702005800027020201010250201010100102005000100

11300244271400402442716004024427180040244272000402442722004024427240040244272600402442728004024427300040244273200402442734004024427360040244273800402442740004024427420040244274400402442746004024427480040244275000402442755004024427600040

00560270125

UBB NO

869993100950786999310294138699931009552869993102942086999310195758699931029727869993102974186999310297658699931029789869993102992586999310299188699931028157869993102961186986734504318699931029574869867349331586986734411878698673497047

869867349012386986734901308698673457614869867349015486986734901618698673457621869867345763886986734901928698673490208869867349021586986734902228698673490246869867349025386986734902608698673490277869867345764586986734903078698673490314869867349032186986734903388698673490345

8699931010923

DESCRIPTION

2.DESIGN TRAYLOCKING TI ELASTIC PIN (L-TEP) 5 X200 MMLOCKING TI ELASTIC PIN (L-TEP) 5 X250 MMLOCKING TI ELASTIC PIN (L-TEP) 5 X300 MMLOCKING TI ELASTIC PIN (L-TEP) 5X350 MMLOCKING TI ELASTIC PIN (L-TEP) 5X400 MMAWL 5.5MMCURVED AWL 5.5MMLOCKING TEP BENDER 4MM-5MMLOCKING TEP INSERTER 4MM-5MMLOCKING TEP IMPACTOR-EXTRACTOR RODLOCKING TEP FINAL IMPACTORBONE HAMMER SMALL WITH SLOTTED ENDLOCK. NAIL EXTRACTOR HOOKBONE DRILL 2,7 X 200 MMTHREADED DRILL SLEEVE Ø 2.7 (40 MM)SCREW DRIVER QUICK TIP 2.5XØ5X120 MMSOFT SCREW DRIVER QUICK SMALLDEPTH GAUGE - LOWER EXTREMITY PLATES

L-TEP SCREW TRAY Ø 4-5 MMCANCEL. LOCK. SCREW TI 4 X 14 MMCANCEL. LOCK. SCREW TI 4 X 16 MMCANCEL. LOCK. SCREW TI 4 X 18 MMCANCEL. LOCK. SCREW TI 4 X 20 MMCANCEL. LOCK. SCREW TI 4 X 22 MMCANCEL. LOCK. SCREW TI 4 X 24 MMCANCEL. LOCK. SCREW TI 4 X 26 MMCANCEL. LOCK. SCREW TI 4 X 28 MMCANCEL. LOCK. SCREW TI 4 X 30 MMCANCEL. LOCK. SCREW TI 4 X 32 MMCANCEL. LOCK. SCREW TI 4 X 34 MMCANCEL. LOCK. SCREW TI 4 X 36 MM CANCEL. LOCK. SCREW TI 4 X 38 MMCANCEL. LOCK. SCREW TI 4 X 40 MMCANCEL. LOCK. SCREW TI 4 X 42 MMCANCEL. LOCK. SCREW TI 4 X 44 MMCANCEL. LOCK. SCREW TI 4 X 46 MMCANCEL. LOCK. SCREW TI 4 X 48 MMCANCEL. LOCK. SCREW TI 4 X 50 MMCANCEL. LOCK. SCREW TI 4 X 55 MMCANCEL. LOCK. SCREW TI 4 X 60 MM

CONTAINER 560X270X125 MM

QTY

1222221121111122111

1555555555555555555555

1

4.0-5.0 mm Locking TEP

15

6991412138720191810111617155

16

Pre-op Lateral

Post-op LateralPost-op AP

Pre-op AP

Radiographic Cases

17